Label: MEIJER MEDICATED HEAT- capsaicin patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 30, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                                                                 Purpose

    Capsicum extract 0.025% as Capsaicin..................................Topical Analgesic

  • PURPOSE

    Uses Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises
  • WARNINGS

    Warnings

    • For external use only
    • Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.
    • Allergy Alert: If you are allergic to any ingredients of this product or chili peppers contact a doctor before use
  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with, or at the same time as other external analgesic products
  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist more than 7 days or clear up and occur again within a few days
    • rash, itching or excessive skin irritation develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding consult a healthcare professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swollen, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 12 years of age and older:
    • clean and dry affected area
    • remove patch from film
    • apply to affected area not more than 3 to 4 times daily for 7 days
    • remove patch from the skin after at most 8 hours application
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

    • avoid storing product in direct sunlight
    • protect product from excessive moisture
  • INACTIVE INGREDIENT

    Inactive Ingredients BHT, Ester gum, Isopropyl myristate, Natural rubber, Polybutene, Polyisobutylene, Precipitated calcium carbonate, Propylene carbonate, Quinton, Sorbitan monostearate, Titanium dioxide, YS resin, Zinc oxide

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Meijer Distribution Inc.

    2929 Walker Ave

    Grand Rapids, MI 49544

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    MEIJER MEDICATED HEAT 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-269
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM0.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC PEROXIDE (UNII: 0I969DVM77)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-269-641 in 1 CARTON
    13 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2013
    Labeler - Meijer (006959555)